BEUDAMED
    FDA Adverse Event Death Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 5024647 · Received August 24, 2015

    Report

    Report Number
    3004066202-2015-00379
    Event Type
    Death
    Date Received
    August 24, 2015
    Date of Event
    March 4, 2015
    Report Date
    November 9, 2015
    Manufacturer
    INVATEC TECHNOLOGY CENTER GMBH
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF DEATH - MONTH AND YEAR VALID.

    Additional Manufacturer Narrative · 1

    DATE OF DEATH IS PROVIDED AS THE (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: IT IS REPORTED THAT APPROXIMATELY 20 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED LUNG CANCER RESULTING IN PATIENT DEATH APPROXIMATELY 3 MONTHS LATER. INVESTIGATOR ASSESSED THE EVENT TO BE NOT RELATED TO THE STUDY DEVICE, PROCEDURE OR PACLITAXEL.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE TWO IN.PACT ADMIRAL PACLITAXEL ELUTING PTA BALLOON CATHETERS WERE USED TO TREAT THE RIGHT MID SFA. THE PATIENT EXPIRED APPROXIMATELY 2 YEARS POST INDEX PROCEDURE. THE CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558003 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU INVATEC TECHNOLOGY CENTER GMBH 2D029315

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Death